Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01HD092062 | U.S. NIH Grant/Contract | View source | |
| 7428 | Other Identifier | New York State Psychiatric Institute Institutional Review Board |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
Not provided
Not provided
Not provided
Not provided
The primary aim of this study is to determine if a behavioral intervention targeting maternal caregiving of young infants can increase infant sleep and reduce fuss/cry behavior, and thereby (1) reduce the incidence and/or severity of postpartum maternal depression and (2) improve the quality of the mother-infant interaction and subsequent child development. Specifically, the study team will investigate: (1) the effectiveness of the intervention compared to usual care; (2) if the effects of the intervention can be detected in the assessments of the quality of mother-infant interaction; (3) if there are prenatal and/or postnatal biomarkers that can help identify infants whose behavior is more likely to play a role in their mothers' depression; (4) if these markers differentiate which infants will be most responsive to the intervention(s); and (5), if assessments of brain function at birth and at 4-6 weeks of age provide biological nodal points for identifying the effects of the intervention on infant brain development. Participants will be recruited during their 2nd trimester, and will be randomly separated into one of two groups: a group that receives coaching in parenting techniques 3 coaching sessions and 2 check-in sessions or one that receives treatment as usual.
Of the nearly 4 million mothers delivering live births each year in the United States, approximately 560,000 - or 14% - will develop major or minor depression within the first four months postpartum, when the rate peaks. This number dwarfs prevalence rates for gestational diabetes (2-5%) and is comparable to preterm birth (11.4%). Postpartum depression (PPD) has substantial consequences: poorer maternal quality of life, significant emotional suffering, and suicide risk. PPD predicts diminished mother-infant bonding, and poor outcomes in social-emotional and, in some groups, cognitive development. PPD is undertreated in part because women are reluctant to seek treatment due to the stigma associated with mental health care, logistical barriers to at-tending added health care appointments, and disinclination to take medications while breastfeeding. Of preventive interventions, few embed services in obstetrical care or leverage the unique mother-infant dyadic orientation of the childbearing period. The investigators developed a novel intervention based on the conceptualization of maternal depression as a potential disorder of the mother-infant dyad, and one that can be approached through psychological and behavioral changes in the mother - commencing before birth - that affect her and the child. PREPP (Practical Resources for Effective Postpartum Parenting) enrolls distressed pregnant women at risk for PPD, spans late pregnancy to the 6 week postpartum check up, comprises four in-person 'coaching' sessions adjunctive to obstetrical (OB) prenatal and postnatal appointments, one phone session, and imparts (a) mindfulness and self-reflection skills, (b) parenting skills, and (c) psycho-education.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Practical Resources for Effective Postpartum (PREPP) | Experimental | A psychotherapeutic preventive intervention that involves psychoeducation and cognitive behavioral techniques. |
|
| Enhanced Treatment as Usual | Active Comparator | Psychoeducation about Postpartum Depression, referral to treatment in the community and monitoring |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Practical Resources for Effective Postpartum Parenting (PREPP) | Behavioral | A preventive psychotherapy intervention for PPD: Participants in this arm of the study receive PREPP (Practical Resources for Effective Postpartum Parenting). PREPP is a brief preventive intervention for Postpartum Depression that focuses on the birthing parent-infant dyad and consists of 5 sessions that take place during pregnancy through 6 weeks postpartum carried out by study clinicians referred to as 'coaches.' The sessions of this preventive psychotherapy are comprised of three components: (a) mindfulness and self-reflection skills, (b) parenting skills and (c) psycho-education. |
| Measure | Description | Time Frame |
|---|---|---|
| Score on the Edinburgh Postnatal Depression Scale (EPDS) | Maternal mood: Postpartum Depression Symptoms will be measured by Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a 10-item questionnaire that was developed to identify women who have postpartum depression. Items of the scale correspond to various clinical depression symptoms, such as guilt feeling, sleep disturbance, low energy, anhedonia, and suicidal ideation. Overall assessment is done by total score, which is determined by adding together the scores for each of the 10 items. Scores range from 0 to 30, with higher scores indicate more depressive symptoms (worse outcome). | Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum |
| Score on the Pittsburgh Sleep Quality Index (PSQI) | Maternal perception of sleep quality: The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire that assesses sleep quality and disturbances over a 1-month time interval. A total of 19 individual items generate 7 "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Scores range from 0 to 21, where lower scores indicate a healthier sleep quality (better outcome). | Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum |
| Score on HRSD-24 | The Hamilton Rating Scale for Depression (HRSD), also called the Hamilton Depression Rating Scale (HDRS), sometimes also abbreviated as HAM-D, is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. The patient is rated on 24 items scored either on a 3-point (0-2) or 5-point (0-4) Likert-type scale. Total scores range from 0 to 74 with a lower score indicating a better outcome. | Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum |
| Score on the PHQ-9 | The nine-item Patient Health Questionnaire (PHQ-9) is a depressive symptom scale and diagnostic tool introduced in 2001 to screen adult patients in primary care settings. The instrument assesses for the presence and severity of depressive symptoms and a possible depressive disorder. It is scored by simply adding up the individual items' scores. Scores range from 0 to 27 with a lower score indicating a better outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Total Nocturnal Sleep Duration - Brief Infant Sleep Questionnaire (BISQ) | The BISQ is a parent-reported questionnaire on infants/toddler (0-29 months) sleep over 7 days | 6 weeks and 16 weeks postpartum |
| Total Daytime Sleep Duration - Brief Infant Sleep Questionnaire (BISQ) |
| Measure | Description | Time Frame |
|---|---|---|
| Total Daily Minutes of Sleep Reported on the Self-Reported Sleep Log (Mother) | Self-reported sleep time was recorded by participants each night over a span of 7 days. | 28-32 weeks gestation (prenatal), 34-39 weeks gestation (prenatal), 6 weeks postpartum, 16 weeks postpartum |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Catherine Monk, PhD | Columbia University | Principal Investigator |
| Elizabeth Werner, PhD | Columbia University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York State Psychiatric Institute | New York | New York | 10032 | United States |
De-identified data may be made available to other researchers.
After the completion of the study
Permission of the PI
Not provided
Only mothers were enrolled, and infants were assessed for efficacy
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Practical Resources for Effective Postpartum (PREPP) | Participants received the experimental PREPP intervention. |
| FG001 | Enhanced Treatment as Usual | Participants received enhanced treatment as usual (ETAU): Postpartum Depression psychoeducation, mood assessments, and referral for treatment if needed or requested by the participant. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Practical Resources for Effective Postpartum (PREPP) | Participants received the experimental PREPP intervention. |
| BG001 | Enhanced Treatment as Usual | Participants received enhanced treatment as usual (ETAU): Postpartum Depression psychoeducation, mood assessments, and referral for treatment if needed or requested by the participant. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Score on the Edinburgh Postnatal Depression Scale (EPDS) | Maternal mood: Postpartum Depression Symptoms will be measured by Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a 10-item questionnaire that was developed to identify women who have postpartum depression. Items of the scale correspond to various clinical depression symptoms, such as guilt feeling, sleep disturbance, low energy, anhedonia, and suicidal ideation. Overall assessment is done by total score, which is determined by adding together the scores for each of the 10 items. Scores range from 0 to 30, with higher scores indicate more depressive symptoms (worse outcome). | Data for this outcome was only collected from participants who were able to attend a session to receive the intervention. Data was not collected from participants who did not attend a session. | Posted | Mean | Standard Error | score on a scale | Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum |
|
During each assessment session, from 20-29 weeks gestation to 16 weeks postpartum, approximately 21- 36 weeks of participation
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Practical Resources for Effective Postpartum (PREPP) | Participants received the experimental PREPP intervention. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth Werner, Ph.D. | Columbia University | 646-774-8945 | ew150@cumc.columbia.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 12, 2024 | Sep 5, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
Two groups: One receives PREPP prevention intervention and the other group receives Enhanced Treatment as Usual (psychoeducation about Postpartum Depression, referral and monitoring)
Not provided
Not provided
The person administering the outcome measures is blind to participant group.
|
|
| Enhanced Treatment As Usual (ETAU) | Behavioral | Psychoeducation, Clinical Assessment, Potential Referral: Participants receive "usual care" along with Postpartum Depression psychoeducation and enhanced support for finding perinatal mental healthcare treatment when appropriate by meeting with a study clinician specifically assigned to provide ETAU in this study at three times that are aligned with PREPP sessions that span from pregnancy to 6 weeks postpartum. At the first contact, participants meet with their assigned ETAU clinician and are given information about PPD, a brief clinical mental health assessment, and a referral for treatment if warranted or requested; the second session is a follow-up mental health clinical assessment with the study clinician and a referral for treatment if warranted or requested; at the third session, participants meet again with their study clinician and receive a mental health assessment, review relevant psychoeducation on PPD and are referred to treatment when appropriate. |
|
|
| Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum |
| Hamilton Anxiety Scale (HRSA) | The scale consists of 14 items designed to assess the severity of a patient's anxiety. The patient is rated by on 14 items scored on a 5-point (0-4) Likert-type scale. Total scores range from 0 to 56 with a lower score indicating a better outcome. | Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum |
| Sleep Efficiency (SEact) of the Mothers | Sleep Efficiency (SEact) was measured by an activity monitor worn by the participants continuously over 7 days. SEact is reported as a percent of time spent asleep during the total time spent in bed. | 28-32 weeks gestation (prenatal), 34-39 weeks gestation (prenatal), 6 weeks postpartum, 16 weeks postpartum |
The BISQ is a parent-reported questionnaire on infants/toddler (0-29 months) sleep over 7 days. |
| 6 weeks and 16 weeks postpartum |
| Total Number of Instances of Waking up at Night - Brief Infant Sleep Questionnaire (BISQ) | The BISQ is a parent-reported questionnaire on infants/toddler (0-29 months) sleep over 7 days. | 6 weeks and 16 weeks postpartum |
| Total Settling Time to Fall Asleep for the Night - Brief Infant Sleep Questionnaire (BISQ) | The BISQ is a parent-reported questionnaire on infants/toddler (0-29 months) sleep over 7 days. | 6 weeks and 16 weeks postpartum |
| Daily Minutes of Infant Crying Over 4 Days | Cry behavior will be measured by The Baby Day Diary, which is a 24-hour diary of infant and parental behavior for days. The number of minutes for the crying behavior is averaged over a span of 4 days, with a higher number indicating a worse outcome. | 6 weeks and 16 weeks postpartum |
| Length of Longest Sleep at Night for Infants Over 4 Days | Sleep behavior will be measured by The Baby Day Diary, which is a 24-hour diary of infant and parental behavior for days. The number of minutes of sleep is averaged over a span of 4 days. A higher number indicates a better outcome. | 6 weeks and 16 weeks postpartum |
| Total Sleep Time (TSTact) in the Mothers | TSTact was measured by an activity monitor worn by the participants continuously over 7 days. | 28-32 weeks gestation (prenatal), 34-39 weeks gestation (prenatal), 6 weeks postpartum, 16 weeks postpartum |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Participants received the experimental PREPP intervention. |
| OG001 | Enhanced Treatment as Usual | Participants received enhanced treatment as usual (ETAU): Postpartum Depression psychoeducation, mood assessments, and referral for treatment if needed or requested by the participant. |
|
|
| Primary | Score on the Pittsburgh Sleep Quality Index (PSQI) | Maternal perception of sleep quality: The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire that assesses sleep quality and disturbances over a 1-month time interval. A total of 19 individual items generate 7 "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Scores range from 0 to 21, where lower scores indicate a healthier sleep quality (better outcome). | Data for this outcome was only collected from participants who were able to attend a session to receive the intervention. Data was not collected from participants who did not attend a session. | Posted | Mean | Standard Error | score on a scale | Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum |
|
|
|
| Primary | Score on HRSD-24 | The Hamilton Rating Scale for Depression (HRSD), also called the Hamilton Depression Rating Scale (HDRS), sometimes also abbreviated as HAM-D, is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. The patient is rated on 24 items scored either on a 3-point (0-2) or 5-point (0-4) Likert-type scale. Total scores range from 0 to 74 with a lower score indicating a better outcome. | Data for this outcome was only collected from participants who were able to attend a session to receive the intervention. Data was not collected from participants who did not attend a session. | Posted | Mean | Standard Error | score on a scale | Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum |
|
|
|
| Primary | Score on the PHQ-9 | The nine-item Patient Health Questionnaire (PHQ-9) is a depressive symptom scale and diagnostic tool introduced in 2001 to screen adult patients in primary care settings. The instrument assesses for the presence and severity of depressive symptoms and a possible depressive disorder. It is scored by simply adding up the individual items' scores. Scores range from 0 to 27 with a lower score indicating a better outcome. | Data for this outcome was only collected from participants who were able to attend a session to receive the intervention. Data was not collected from participants who did not attend a session. | Posted | Mean | Standard Error | score on a scale | Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum |
|
|
|
| Primary | Hamilton Anxiety Scale (HRSA) | The scale consists of 14 items designed to assess the severity of a patient's anxiety. The patient is rated by on 14 items scored on a 5-point (0-4) Likert-type scale. Total scores range from 0 to 56 with a lower score indicating a better outcome. | Data for this outcome was only collected from participants who were able to attend a session to receive the intervention. Data was not collected from participants who did not attend a session. | Posted | Mean | Standard Error | score on a scale | Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum |
|
|
|
| Primary | Sleep Efficiency (SEact) of the Mothers | Sleep Efficiency (SEact) was measured by an activity monitor worn by the participants continuously over 7 days. SEact is reported as a percent of time spent asleep during the total time spent in bed. | Data for this outcome could not be collected from participants who did not wear the activity monitor continuously for 7 days | Posted | Mean | Standard Deviation | percent | 28-32 weeks gestation (prenatal), 34-39 weeks gestation (prenatal), 6 weeks postpartum, 16 weeks postpartum |
|
|
|
| Secondary | Total Nocturnal Sleep Duration - Brief Infant Sleep Questionnaire (BISQ) | The BISQ is a parent-reported questionnaire on infants/toddler (0-29 months) sleep over 7 days | Data was not collected from participants who did not complete this measure. | Posted | Mean | Standard Deviation | hours | 6 weeks and 16 weeks postpartum |
|
|
|
| Secondary | Total Daytime Sleep Duration - Brief Infant Sleep Questionnaire (BISQ) | The BISQ is a parent-reported questionnaire on infants/toddler (0-29 months) sleep over 7 days. | Data was not collected from participants who did not complete this measure. | Posted | Mean | Standard Deviation | hours | 6 weeks and 16 weeks postpartum |
|
|
|
| Secondary | Total Number of Instances of Waking up at Night - Brief Infant Sleep Questionnaire (BISQ) | The BISQ is a parent-reported questionnaire on infants/toddler (0-29 months) sleep over 7 days. | Data was not collected from participants who did not complete this measure. | Posted | Mean | Standard Deviation | awakenings | 6 weeks and 16 weeks postpartum |
|
|
|
| Secondary | Total Settling Time to Fall Asleep for the Night - Brief Infant Sleep Questionnaire (BISQ) | The BISQ is a parent-reported questionnaire on infants/toddler (0-29 months) sleep over 7 days. | Data was not collected from participants who did not complete this measure. | Posted | Mean | Standard Deviation | minutes | 6 weeks and 16 weeks postpartum |
|
|
|
| Secondary | Daily Minutes of Infant Crying Over 4 Days | Cry behavior will be measured by The Baby Day Diary, which is a 24-hour diary of infant and parental behavior for days. The number of minutes for the crying behavior is averaged over a span of 4 days, with a higher number indicating a worse outcome. | Posted | Mean | Standard Deviation | minutes per day | 6 weeks and 16 weeks postpartum |
|
|
|
| Secondary | Length of Longest Sleep at Night for Infants Over 4 Days | Sleep behavior will be measured by The Baby Day Diary, which is a 24-hour diary of infant and parental behavior for days. The number of minutes of sleep is averaged over a span of 4 days. A higher number indicates a better outcome. | Posted | Mean | Standard Deviation | minutes | 6 weeks and 16 weeks postpartum |
|
|
|
| Secondary | Total Sleep Time (TSTact) in the Mothers | TSTact was measured by an activity monitor worn by the participants continuously over 7 days. | Data for this outcome was not collected from participants who did not wear the activity monitor continuously for 7 days | Posted | Mean | Standard Deviation | minutes | 28-32 weeks gestation (prenatal), 34-39 weeks gestation (prenatal), 6 weeks postpartum, 16 weeks postpartum |
|
|
|
| Other Pre-specified | Total Daily Minutes of Sleep Reported on the Self-Reported Sleep Log (Mother) | Self-reported sleep time was recorded by participants each night over a span of 7 days. | Posted | Mean | Standard Deviation | minutes per day | 28-32 weeks gestation (prenatal), 34-39 weeks gestation (prenatal), 6 weeks postpartum, 16 weeks postpartum |
|
|
|
| 0 |
| 88 |
| 0 |
| 88 |
| 0 |
| 88 |
| EG001 | Enhanced Treatment as Usual | Participants received enhanced treatment as usual (ETAU): Postpartum Depression psychoeducation, mood assessments, and referral for treatment if needed or requested by the participant. | 0 | 87 | 0 | 87 | 0 | 87 |
Not provided
Not provided
Not provided
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| 6 week |
|
|
| 12 week |
|
|
| 16 week |
|
|
| 6 week |
|
|
| 12 week |
|
|
| 16 week |
|
|
| 6 week |
|
|
| 12 week |
|
|
| 16 week |
|
|
| 6 week |
|
|
| 12 week |
|
|
| 16 week |
|
|
| 34-39 weeks gestation |
|
|
| 6 week postpartum |
|
|
| 16 week postpartum |
|
|
| 16 weeks |
|
|
| 16 weeks |
|
|
| 16 weeks |
|
|
| 16 weeks |
|
|
| 34-39 weeks gestation |
|
|
| 6 weeks postpartum |
|
|
| 16 weeks postpartum |
|
|
| 6 weeks postpartum |
|
| 16 weeks postpartum |
|